Reported May 28, 2014 · Terminated
Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and…
Philips Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems, Inc. · 3000 Minuteman Rd · Andover, MA · 01810-1032
Is this the product you have?
- Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters.
- Lot codes and dates
- Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0.
- Amount recalled
- 188,520 devices
Where it was sold
- Nationwide
Why it was recalled
The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode.
This product could cause temporary or reversible health problems — stop using it.
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